人血清CA15-3化学发光免疫分析方法的建立及应用

Development of a Method of Chemiluminescence Immunoassay for CA15-3 with Native Produced Apparatus and Kits in This Laboratory

目的：建立人血清CA15-3化学发光免疫分析方法并在临床检测中的应用。方法：使用CA15-3定量测定试剂盒（化学发光法）检测1232例，其中754例正常人及478例病人血清标本，并与CA15-3电化学发光全自动免疫分析方法进行对比。结果：灵敏度0．032KU／L，线性范围1．2～160KU／L，与CA125及CEA无交叉反应，样本中抗凝剂量的柠檬酸钠、肝素、EDTA-Na2对测定结果没有影响。添加回收率和稀释回收率为90％～110％，分析内和分析间变异均〈10．0％。该方法正常参考值为（0～23．08）KU／L（95％可信限）。ECLA测定结果与本法相比，临床总符合率为96．65％。结论：该方法灵敏度高、特异性好、稳定性强、检测范围宽，有良好的准确性和重复性，完全可以替代进口化学发光试剂用于临床样本的检测。

Objective To establish a method of chemiluminescence immunoassay （CLIA） developed in this laboratory for serum CA15 - 3 determination with native produced apparatus and kits. Methods Serum CA15 - 3 contents were determined with CLIA, using native made apparatus and kits developed in our laboratory. Altogether 1232 specimens were tested （478 from patients and 754 from controls）; the results were compared with those obtained with Roche - Elecsys 2010. Results The sensitiveity of the assay was 0.034KU/L. Linear range was 1.2～160KU/L. There were no cross - reactions with CA125 and CEA. Adding necessary amount of anticoagulants （sodium citrate, heparin, EDTA - Na2） to the specimen had no effect on the assay results. Additional or dilutional recovery rate was 90%～110%. Both the inter and intra - CV were less than 10.0%. Normal range of CA15 - 3 concentration with this method was （0～23.08 ）KU/L （95% confidence limit）. Results of this assay had a coincidence rate of 96.65% to those with the gold - standard Elecsys 2010 ECLIA. Conclusion The newly developed method of CLIA was sensitive, specific stable, accurate with good reproducibility. The imported apparatus and kits could be adequately replaced.